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The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
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The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM

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- Interactions: Sponsors, Clinical Operations and CDM …

- Interactions: Sponsors, Clinical Operations and CDM
- Risk-Based Monitoring
- Challenges for Sponsors
- Challenges for Monitors
- Challenges for CDM
- Implementation – Will there be any affect on data quality or integrity?
- Will the Risked-Based Approach require roles/skill set adjustments?

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  • 1. The FDA Guidance of Risk-BasedApproach to Monitoring as Viewed From CDM Presented By William Gluck, PhD VP, DATATRAK Clinical and Consulting Services DATATRAK International, Inc. For
  • 2. AgendaInteractions: Sponsors, Clinical Operations and CDMRisk-Based Monitoring – Challenges for Sponsors – Challenges for Monitors – Challenges for CDMImplementation – Will there be any affect on data quality or integrity?Will the Risked-Based Approach require roles/skill set adjustments?
  • 3. Traditional Paper-Based Work-FlowPatientData Database
  • 4. Risked-Based Monitoring Work-Flow CentralizedSites Database CRA CDM
  • 5. Supporting Risked-Based Monitoring – Challenges for Sponsors• “The most important tool for ensuring human subject protection and high-quality data is a well- designed and articulated protocol.”• Guidance intends to assist sponsors in developing risk-based monitoring strategies and plans – Tailored to the specific human subject protection and data integrity risks of the trial – Focuses on critical study parameters – Encourages use of a combination of monitoring activities – Encourages greater reliance on centralized monitoring practices, where appropriate – it is OK not to do 100% SDV
  • 6. Supporting Risked-Based Monitoring – Challenges in Clinical Operations• Trial specific• Describe monitoring methods, responsibilities, and requirements• Components to consider – Description of monitoring approaches (e.g., timing, intensity, activities, documentation) – Targeted SDV – Communication of monitoring results – Management of noncompliance – Training and study-specific information – Monitoring plan amendments
  • 7. Supporting Risked-Based Monitoring – Challenges in CDM• Centralized Monitoring• Quality and Integrity Checks – Increased checks – Increased data collection• Technologically Few Challenges• Process/Workflow Flow – KEY!
  • 8. Data Quality/Integrity• Identify critical study data and processes, e.g. – Endpoints – Serious Adverse Events – Randomization/ Blinding – Consent – Eligibility Criteria – Risks specific to protocol design and conduct• Perform and document a risk assessment to identify risks to these critical data and processes• Design plans tailored to address important and likely risks identified during risk assessment
  • 9. Role or Skill Set Adjustments Needed to Support Risked-Based Monitoring• Sponsors• Site Coordinators/Staff• CRAs/Monitors – Increases in support and technology skills• CDM – Increases in technology process – Increases in training skills
  • 10. Summary• From the perspective of CDM – Need coordination in planning across functional groups/departments – No overwhelming hurdles to implementation• Guidance reflects acknowledgment that changes to the clinical trial enterprise are OK• Process integration is key to efficient use of resources and to add quality
  • 11. William Gluck, Ph.D.VP, DATATRAK Clinical and Consulting Services Datatrak International, Inc. Phone: 919-651-0222 Cell: 919-522-9681 E-Mail: Bill.Gluck@datatrak.net

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